OpGen(US:OPGN)2023-11-14 21:30Business Operations - The Company discontinued its Acuitas AMR Gene Panel diagnostic test on October 18, 2023, with final orders processed earlier this year [145]. - Curetis and Ares Genetics filed for insolvency on November 6, 2023, following unsuccessful efforts to sell their businesses or access additional capital [146]. - The Unyvero Lower Respiratory Tract test detects over 90% of common pneumonia-causing agents in hospitalized patients and provides results in under five hours [147]. - The Unyvero UTI test is currently being developed for FDA clearance, with a De Novo classification request submitted in April 2023 [148]. - The Unyvero A50 system tests for up to 130 diagnostic targets in under five hours and has been FDA-cleared since 2018 [152]. - The Company has a distribution agreement with Fisher Healthcare, allowing them to sell to existing U.S. Unyvero customers [153]. - Revenue is generated from product sales, laboratory services, and collaboration revenue, including AI-powered solutions from Ares Genetics [156]. Financial Performance - The Company recognized revenues of €42 thousand and €0.6 million during the three and nine months ended September 30, 2023, related to a collaboration with FIND, totaling €0.87 million [150]. - Total revenue for the three months ended September 30, 2023, increased approximately 56% to $699,022 compared to $448,713 in the same period in 2022 [158]. - Product sales rose to $558,965, a 55% increase from $359,112 in the prior year, driven by higher international Unyvero system and cartridge sales [160]. - Laboratory services revenue increased by approximately 52% to $47,135, attributed to enhanced sequencing and analysis services [160]. - Collaboration revenue surged by approximately 59% to $92,922, primarily due to a collaboration agreement with FIND [160]. - Total revenue for the nine months ended September 30, 2023, increased approximately 25% to $2,348,601 compared to $1,885,663 in the same period in 2022 [163]. Operating Expenses - Total operating expenses for the three months ended September 30, 2023, decreased approximately 69% to $4,264,647 from $13,962,011 in the same period in 2022 [159]. - Research and development expenses decreased approximately 41% to $1,201,865, mainly due to reduced payroll costs and the conclusion of a clinical trial [161]. - Total other expense for the three months ended September 30, 2023, decreased to $497,332 from $590,684 in the same period in 2022, primarily due to reduced interest expenses [162]. Cash Flow and Liquidity - As of September 30, 2023, cash and cash equivalents were $0.3 million, down from $7.4 million at December 31, 2022 [168]. - On October 11, 2023, the company entered into a Preferred Stock Purchase Agreement for aggregate gross proceeds of $1.0 million [173]. - OpGen's cash available to fund its business operations is significantly limited, raising substantial doubt about the Company's ability to continue as a going concern [177]. - For the nine months ended September 30, 2023, net cash used in operating activities was $(12,643,099), compared to $(16,454,854) for the same period in 2022, indicating a reduction in cash outflow [179]. - The principal source of liquidity is from financing activities, including issuances of equity and debt securities, with net cash provided by financing activities of $6,275,625 for the nine months ended September 30, 2023 [179]. - The Company has created additional banking relationships to diversify its holdings after regaining access to accounts at Silicon Valley Bank [178]. - Future disruptions in financial institutions could adversely affect the Company's ability to access cash and cash equivalents, impacting its financial position [178]. Debt and Obligations - The net loss for the nine months ended September 30, 2023, was $15.6 million, improved from a net loss of $26.7 million in the same period of 2022 [180]. - As of September 30, 2023, outstanding borrowings under all tranches were €9.4 million (approximately $9.9 million), including deferred interest of €1.4 million (approximately $1.5 million) [184]. - The Company has entered into a Standstill Agreement with the EIB regarding €3 million in principal plus accumulated interest due on June 22, 2023, delaying any action until November 30, 2023 [186]. - The first tranche of approximately €13.4 million was fully repaid by April 2023, following a restructuring agreement with the EIB [185]. - The third tranche of €5.0 million will become due in June 2024 unless restructured along with the second tranche [187].